BETHESDA, Md., March 12 /PRNewswire-FirstCall/ -- Micromet, Inc.
(NASDAQ: MITI), a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation
and autoimmune diseases, today announced that it is regaining from
its partner MedImmune the rights in North America to its most
advanced BiTE antibody candidate, blinatumomab, also known as
MT103. In Europe, Micromet is conducting a phase 2 clinical trial
with blinatumomab for the treatment of patients with acute
lymphoblastic leukemia and a phase 1 clinical trial for the
treatment of patients with non-Hodgkin's lymphoma. In addition, the
two companies plan to initiate a research program for the
development of a new BiTE antibody for the treatment of
hematological cancers. Micromet also announced its financial
results for the fourth quarter and full year ended December 31,
2008. "We had a successful 2008 and are excited about the prospects
for 2009. Our lead BiTE antibody program blinatumomab reported
encouraging clinical data from phase 1 and phase 2 clinical trials
last year, which form the basis for advancing the program towards
its first pivotal clinical trial. We are pleased to regain North
American rights to blinatumomab from our partner and are looking
forward to taking control of the worldwide development of the
program," stated Christian Itin, President and Chief Executive
Officer of Micromet. "With our successful financing and partnering
activities last year and early this year, we are well positioned to
move our programs to the next value step." Recent Developments
relating to Blinatumomab and Micromet's Collaboration with
MedImmune: In March 2009, MedImmune elected to return its license
rights to blinatumomab to Micromet. Micromet will assume
responsibility for the worldwide clinical development and
commercialization of blinatumomab. MedImmune will complete the
development of the commercial scale manufacturing process for
blinatumomab at its cost. Upon the first marketing approval of
blinatumomab in the United States, MedImmune will have a one-time
option to reacquire the commercialization rights in North America
at pre-defined terms. Micromet's clinical development activities
with blinatumomab in Europe will continue unchanged. With the
return of control over the development of blinatumomab in North
America, Micromet will be in a position to align the European and
US development activities. Micromet will provide an update later
this year on its plans for the development of blinatumomab in the
United States. The companies plan to initiate a research program
for the development of a new BiTE antibody for the treatment of
hematological cancers. MedImmune has an exclusive license to
develop and commercialize the new BiTE antibody in North America,
while Micromet owns all rights to the new BiTE antibody outside of
North America. MedImmune will reimburse Micromet for its expenses
in the performance of certain research and preclinical development
activities to be conducted by Micromet. In addition, MedImmune will
be required to make milestone payments upon the achievement of
certain development milestones, and, if it receives marketing
approval, to pay a royalty on net sales of the new BiTE antibody in
North America. Summary of Key Clinical Data Presented in 2008: --
In December, Micromet presented clinical data on blinatumomab at
the American Society of Hematology meetings in San Francisco. The
presentations included an oral presentation of the phase 1 clinical
trial data of blinatumomab in patients with relapsed non-Hodgkin's
lymphoma and a poster presentation of the first interim data from
its phase 2 clinical trial of blinatumomab in adult patients with
acute lymphoblastic leukemia. -- In September, Micromet presented
the first clinical data from a phase 1b clinical trial studying the
combination of adecatumumab with docetaxel in late stage metastatic
breast cancer patients at the European Society for Medical Oncology
in Stockholm, Sweden. -- In August, Micromet presented the first
peer-reviewed publication of clinical data on blinatumomab from the
phase 1 clinical study in relapsed non-Hodgkin's lymphoma patients.
These data were published in the journal Science (321: 974-977
(2008)). -- In April, Micromet presented the first pre-clinical
data on new BiTE antibodies targeting EGFR, HER-2, MCSP and CD33.
In addition, data was presented from animal studies testing the
subcutaneous delivery of blinatumomab and MT110. Financings and
related Events in 2008: -- In December, Micromet entered into a new
committed equity financing facility with Kingsbridge Capital
Limited, replacing a similar facility that was established in 2006.
Under the renewed facility, Kingsbridge has committed to purchase,
subject to certain restrictions, limitations and conditions, up to
$75 million of common stock at the time and in the amounts deemed
suitable to Micromet, until December 1, 2011. Micromet is not
obligated to sell to Kingsbridge any of the $75 million of common
stock available under the facility, and there are no minimum
commitments or minimum use penalties. -- In November, Micromet was
added to the NASDAQ Biotechnology Index. -- In October, Micromet
closed a sale of its common stock in a private placement
transaction that yielded $40 million in gross proceeds. Program
Updates in 2009: Consistent with its January 5, 2009, press release
titled "Micromet Key Events for 2009," Micromet intends to provide
an update on its research and development programs at the following
events: -- April 12 to 16, 2009: Update on several preclinical BiTE
antibodies at the American Association for Cancer Research (AACR)
in Denver, CO. -- April 24, 2009: Micromet will hold an R&D
meeting in New York, NY for investors and analysts to provide a
review of its product pipeline. -- May 29 to June 5, 2009: Update
on a phase 1b clinical trial combining adecatumumab with docetaxel
in late stage metastatic breast cancer patients at the annual
meeting of the American Society for Clinical Oncology (ASCO) in
Orlando, FL. -- June 4 to 7, 2009: Update on the phase 2 clinical
trial with blinatumomab in acute lymphoblastic leukemia (ALL)
patients at the 14th Congress of the European Hematology
Association (EHA) in Berlin, Germany. -- September 20 to 24, 2009:
First interim data from a phase 1 clinical trial with MT110, an
EpCAM-targeting BiTE antibody, in patients with metastatic
gastrointestinal and lung cancers at the joint 15th Congress of the
European Cancer Organisation (ECCO) and 34th Congress of the
European Society for Medical Oncology (ESMO) in Berlin, Germany. --
December 5 to 8, 2009: Update on a phase 2 clinical trial with
blinatumomab in ALL patients and final results from a phase 1
clinical trial in late stage NHL patients at the annual meeting of
the American Society for Hematology (ASH) in New Orleans, LA.
Additional expected Milestones in 2009: -- In the first half of
2009, we expect to initiate a randomized, controlled, multicenter
phase 2 clinical trial for relapsed colorectal cancer patients
after complete resection of liver metastasis with adecatumumab, an
EpCAM-targeting human monoclonal antibody that we develop in
collaboration with Merck Serono; -- Before the end of 2009, we plan
to initiate an additional phase 2 clinical trial in patients with
non-Hodgkin's lymphoma with blinatumomab. In addition, by mid-2009,
we expect to have completed enrollment in the ongoing phase 2
clinical trial in patients with acute lymphoblastic leukemia. -- By
mid 2009, we expect our partner Nycomed to initiate the first phase
1 clinical trial with MT203, a GM-CSF-neutralizing human monoclonal
antibody, for the treatment of chronic inflammatory and autoimmune
diseases. -- Later in 2009, we expect our partner Morphotek, a
wholly-owned subsidiary of Eisai, to initiate a first phase 1
clinical trial with MT228, a glycolipid-binding human antibody. --
Also later in 2009, we expect our partner TRACON Pharmaceuticals,
Inc. to complete the ongoing phase 1 clinical trial of MT293, a
humanized monoclonal antibody targeting denatured collagen, that is
being developed for the treatment of solid tumors. -- Micromet
intends to publish results from the research and development of its
programs in peer-reviewed scientific and clinical journals
throughout the year. -- As previously stated, Micromet entered into
an agreement with Bayer Schering in January 2009 under which Bayer
Schering has obtained an exclusive option to develop and
commercialize a BiTE antibody against a specified solid tumor
target. We intend to enter into at least one additional corporate
collaboration in 2009. Financial Results: Quarter Ended December
31, 2008 For the three months ended December 31, 2008, Micromet
recognized total revenues of $5.9 million, compared to $7.0 million
for the same period in 2007. Total operating expenses were $12.4
million for the three months ended December 31, 2008, compared to
$13.1 million for the same period in 2007. Loss from operations for
the three months ended December 31, 2008 was $6.5 million, compared
to a loss from operations of $6.1 million for the same period in
2007. For the three months ended December 31, 2008, Micromet
reported a net loss of $5.9 million, or $0.12 per basic and diluted
common share, compared to a net loss of $3.8 million, or $0.09 per
basic and diluted common share, for the same period in 2007. Year
Ended December 31, 2008 For the year ended December 31, 2008,
Micromet recognized total revenues of $27.3 million, compared to
$18.4 million for 2007. Total operating expenses were $53.4 million
for the year ended December 31, 2008, compared to $43.6 million for
2007. Loss from operations for the year ended December 31, 2008 was
$26.1 million, compared to the $25.2 million loss from operations
in 2007. For the year ended December 31, 2008, Micromet reported a
net loss of $33.2 million, or $0.77 per basic and diluted common
share, compared to a net loss of $20.1 million, or $0.55 per basic
and diluted common share, for 2007. The net loss for the year ended
December 31, 2008 includes a non-cash charge of $8.1 million,
reflecting an increase during the year in the fair value of
warrants that we issued in a 2007 private placement transaction,
compared to a $1.8 million non-cash gain for this item in 2007. The
fair value of the warrants is calculated based on the Black-Scholes
model. Increases in our stock price during a reporting period
result in a non-cash expense, while decreases in our stock price
during a reporting period result in non-cash income. Net cash used
in operating activities was $15.7 million for the year ended
December 31, 2008 compared to $14.3 million used in operating
activities for 2007. Micromet's cash and cash equivalents were
$46.2 million as of December 31, 2008. Conference Call and Audio
Webcast Today, March 12, 2009, at 9:00 am U.S. Eastern Time. To
participate in this conference call, dial 800-659-1966 (U.S.) or
617-614-2711 (international), passcode: 20334467. The audio webcast
can be accessed at: http://www.micromet-inc.com/ in the investor
relations section of the website. A replay of the call will be
available from 12:00 pm Eastern Time on March 12, 2009 (6:00 pm
Central European Time) through Thursday, March 19, 2009. The replay
number is 888-286-8010 (U.S.) or 617-801-6888 (international),
passcode: 99301894. About Micromet Micromet, Inc.
(http://www.micromet-inc.com/) is a biopharmaceutical company with
offices in Bethesda, MD and Munich, Germany. The Company is focused
on developing novel, proprietary antibodies for the treatment of
cancer, inflammation and autoimmune diseases. The Company's novel
antibody technology is based on its proprietary BiTE(R) antibody
platform, representing a new class of antibodies that specifically
activate T cells from the patient's own immune system to eliminate
cancer cells or other disease related cells. Four of the Company's
antibodies are currently in clinical trials, with the remainder of
its product pipeline in preclinical development. The Company's lead
program is a BiTE antibody known as blinatumomab, or MT103. It is
in a phase 2 clinical trial for the treatment of patients with
acute lymphoblastic leukemia and a phase 1 clinical trial for the
treatment of patients with non-Hodgkin's lymphoma. Micromet's
second BiTE antibody in clinical development is MT110, which
targets the epithelial cell adhesion molecule (EpCAM). The Company
owns all rights to MT110, which is currently in a phase 1 clinical
trial for the treatment of patients with solid tumors. The
Company's third clinical stage antibody is adecatumumab, also known
as MT201, a traditional human monoclonal antibody that targets
EpCAM-expressing solid tumors. Micromet is developing adecatumumab
in collaboration with Merck Serono in a phase 1b clinical trial
evaluating adecatumumab in combination with docetaxel for the
treatment of patients with metastatic breast cancer. Micromet
licensed a fourth clinical stage antibody, MT293, to TRACON
Pharmaceuticals, Inc. MT293 is being developed in a phase 1
clinical trial for the treatment of patients with cancer. The
Company's preclinical programs include MT203 being developed in
collaboration with Nycomed. MT203 is a traditional human antibody
neutralizing the activity of granulocyte/macrophage colony
stimulating factor (GM-CSF), which has potential applications in
the treatment of inflammatory and autoimmune diseases, such as
rheumatoid arthritis, psoriasis, or multiple sclerosis. Micromet
has granted an exclusive option to Bayer Schering Pharma AG to
license a BiTE antibody against an undisclosed solid tumor target.
Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and
MCSP, respectively, are in different stages of preclinical
development. Forward-Looking Statements This release contains
certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially
different from historical results or from any future results
expressed or implied by such forward-looking statements. These
forward-looking statements include statements regarding the
efficacy, safety and intended utilization of our product
candidates, the development of our BiTE antibody technology, the
return of development and commercialization rights to blinatumomab,
the future development of blinatumomab and a new BiTE antibody
binding to CD19, the conduct, timing and results of future clinical
trials, expectations of the future expansion of our product
pipeline and collaborations, our plans regarding future
presentations of clinical data, our expectations of timing for the
publication of results from our research and development programs,
our ability to draw down on the Committed Equity Financing Facility
with Kingsbridge, and our plans regarding collaborations and other
partnering activities. You are urged to consider statements that
include the words "ongoing," "may," "will," "believes,"
"potential," "expects," "plans," "anticipates," "intends," or the
negative of those words or other similar words to be uncertain and
forward-looking. Factors that may cause actual results to differ
materially from any future results expressed or implied by any
forward-looking statements include the risk that product candidates
that appeared promising in early research, preclinical studies or
clinical trials do not demonstrate safety and/or efficacy in
subsequent clinical trials, the risk that encouraging results from
early research, preclinical studies or clinical trials may not be
confirmed upon further analysis of the detailed results of such
research, preclinical study or clinical trial, the risk that
additional information relating to the safety, efficacy or
tolerability of our product candidates may be discovered upon
further analysis of preclinical or clinical trial data, the risk
that we or our collaborators will not obtain approval to market our
product candidates, the risks associated with reliance on outside
financing to meet capital requirements, and the risks associated
with reliance on collaborators, including MedImmune, Merck Serono,
TRACON and Nycomed, for the funding or conduct of further
development and commercialization activities relating to our
product candidates. These factors and others are more fully
discussed in Micromet's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed with the SEC on November 6,
2008, as well as other filings by the company with the SEC. (Tables
Follow) Micromet, Inc. Condensed Consolidated Balance Sheets (In
thousands, except par value) December 31, December 31, 2008 2007
Assets Current assets: Cash and cash equivalents $46,168 $27,066
Accounts receivable 3,424 4,689 Prepaid expenses and other current
assets 1,950 2,579 Total current assets 51,542 34,334 Property and
equipment, net 3,322 4,390 Goodwill 6,462 6,462 Patents, net 5,250
7,680 Deposits and other assets 959 196 Restricted cash 3,140 3,190
Total assets $70,675 $56,252 Liabilities and Stockholders' Equity
Current liabilities: Accounts payable $710 $2,335 Accrued expenses
6,492 5,285 Warrant liabilities 12,294 5,218 Current portion of
long-term debt obligations - 2,401 Current portion of deferred
revenue 4,054 3,360 Total current liabilities 23,550 18,599
Deferred revenue, net of current portion 7,555 8,366 Other
non-current liabilities 2,025 2,055 Long-term debt obligations, net
of current portion 2,157 2,254 Commitments Stockholders' equity:
Preferred stock, $0.00004 par value; 10,000 shares authorized; no
shares issued and outstanding - - Common stock, $0.00004 par value;
150,000 shares authorized; 50,913 and 40,778 shares issued and
outstanding at December 31, 2008 and December 31, 2007,
respectively 2 2 Additional paid-in capital 227,806 184,014
Accumulated other comprehensive income 5,749 5,895 Accumulated
deficit (198,169) (164,933) Total stockholders´ equity 35,388
24,978 Total liabilities and stockholders' equity $70,675 $56,252
Micromet, Inc. Condensed Consolidated Statements of Operations (In
thousands, except per share amounts) (Unaudited) Three Months Ended
Year Ended December 31, December 31, 2008 2007 2008 2007 Revenues
Collaboration agreements $5,212 $6,751 $25,870 $17,366 License fees
and other 660 234 1,416 1,018 Total revenues 5,872 6,985 27,286
18,384 Operating expenses Research and development 8,534 9,471
39,189 29,191 General and administrative 3,817 3,590 14,163 14,430
Total operating expenses 12,351 13,061 53,352 43,621 Loss from
operations (6,479) (6,076) (26,066) (25,237) Other income (expense)
Interest expense (33) (71) (222) (509) Interest income 91 348 740
938 Change in fair value of warrants 439 41 (8,064) 1,750 Other
income 131 1,817 377 2,932 Net loss $(5,851) $(3,799) $(33,235)
$(20,126) Basic and diluted net loss per common share $(0.12)
$(0.09) $(0.77) $(0.55) Weighted average shares used to compute
basic and diluted net loss per share 50,534 40,757 43,309 36,362
DATASOURCE: Micromet, Inc. CONTACT: US Media: Andrea tenBroek, or
Chris Stamm, +1-781-684-0770, ; US Investors: Susan Noonan,
+1-212-966-3650. ; European Media: Ludger Wess, +49 (40) 8816 5964,
; European Investors: Ines-Regina Buth, +49 (30) 2363 2768, , all
for Micromet, Inc. Web Site: http://www.micromet-inc.com/
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